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The purpose of this study is to assess the bleeding reduction efficacy of toothpaste containing 1.05% Chitosan compared to a regular fluoride toothpaste, and compared to a toothpaste containing 67% bicarbonate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Toothpaste containing 1.05% Chitosan, soft-bristled toothbrush |
|
| Positive control | Active Comparator | Toothpaste containing 67% Bicarbonate, soft-bristled toothbrush |
|
| Negative control | Placebo Comparator | Silica-based NaF Toothpaste, soft-bristled toothbrush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste containing 1.05% Chitosan | Other | Toothpaste containing 1.05% Chitosan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Bleeding | Gingival Bleeding Index described by Saxton and van der Ouderaa (1989). | From baseline to 3 days, 7 days and 14 days after baseline. |
| Gingivitis | Modified Gingival Index (MGI) Lobene et al (1986) | Baseline, and immediately post-brushing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Dental Institute of Chengdu | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D005884 | Gingival Hemorrhage |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D006472 | Oral Hemorrhage |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005882 | Gingival Diseases |
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| ID | Term |
|---|---|
| D048271 | Chitosan |
| D014100 | Toothpastes |
| D001639 | Bicarbonates |
| ID | Term |
|---|---|
| D002686 | Chitin |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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Double-blinded
| Silica-based NaF Toothpaste |
| Other |
Silica-based NaF Toothpaste |
|
| Toothpaste with 67% bicarbonate | Other | Toothpaste containing 67% Bicarbonate |
|
| D010510 |
| Periodontal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |